May 14, 2024

About the Role

Location: #LI-Hybrid, #LI-Distance Worker

Clinical Document Governance Management (CDGM) is accountable for strategy and delivery of clinical document management (CDM) systems, processes, standards and operations of CDM services (including Trial Master File management (TMF), clinical submission readiness, record retention and archiving, Good Documentation Practice capability build) across Novartis globally. In addition, CDGM is driving the transformation of TMF at Novartis, through the introduction and adoption of new technologies, processes and ways of working.

This role will be accountable for leading a team responsible for ensuring effective planning, delivery and oversight of user support and knowledge management activities in relation to clinical document management processes and systems across the Novartis organization,

Key Responsibilities:

• Lead a team delivering user support and knowledge management activities related to the delivery of capability and learning services to help drive adoption of Trial Master File (TMF) and good documentation practices across the business.

• Identifies, plans and drives implementation of CDGM initiatives, projects and process improvement activities to improve clinical document management user support and knowledge management at Novartis.

• Act as CDGM user support and knowledge management contact for key stakeholders, collaborating with them to improve clinical documentation process, systems and capabilities across the organization.

• Delivers excellence in service delivery, including optimization and simplification in compliance with Novartis policies & regulatory requirements, responding in an agile way to new or evolving business priorities.

• Provide robust oversight of 3rd party vendor activities including monitoring balanced performance against SLAs.
Lead or give to multi-functional initiatives or projects, including defining and gaining approval for projects or initiatives, and ensuring work is achieved in line with agreed timeframes and budget.

• Embeds a risk-based approach across the team and in service delivery, ensuring identification, evaluation and management of risks, including mitigation activities.
Set priorities, handle schedules and develop robust resourcing model to support timely delivery of TMF services.

• Support CDGM and business teams in preparation for and during audits, inspections and migration activities. Own CAPAs arising from inspections/audits ensuring they are closed out on time.

• Leads team, recruits, retains, manages and develops associates through coaching and feedback, talent reviews and other available Novartis resources and tools, and champions a safe environment for team dialogue and growth.

**The ideal location for this role is the East Hanover, NJ site but a distant working arrangement may be possible in certain states. Distant workers are responsible for the cost of home office expenses and periodic travel/lodging to the East Hanover, NJ site, as determined necessary by hiring manager. This position will require minimal travel as defined by the business (domestic and or international).

Diversity & Inclusion / EEO

We are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

Accessibility and Reasonable Accommodations: Individuals in need of a reasonable accommodation due to a medical condition or disability for any part of the application process, or to perform the essential functions of a position, please let us know the nature of your request, your contact information and the job requisition number in your message:

Role Requirements

Essential Requirements:
• Education: Advanced degree or combination of Bachelor’s degree in life-sciences/healthcare/pharmacy and relevant Industry experience.

• Minimum of 8 years of working in clinical research and development in the pharmaceutical industry (and/or Contract Research Organization) with specific experience in clinical documentation and/or records & information management.

• Minimum of 3 years’ experience in direct people management or matrix management of project/clinical teams.

• Deep understanding of drug development process, international drug approval procedures and standards (e.g., ICH-E3, ICH-E6, eCTD) and industry-wide standards in clinical document management (e.g., DIA TMF reference model).

• Experience leading user support and knowledge management implementation/programs for GCP applications, good understanding of trial management and clinical systems.

• Demonstrated success in planning and driving multi-functional projects.

• Strong influencing and presentation skills. Ability to communicate effectively at all levels.

Desired Experience:

• Good organizational awareness, including experience working in multi-disciplinary teams, across cultures and geographies.

• Good negotiation, problem solving and conflict resolution skills; experience establishing positive relationships with internal and external stakeholders.

Why Novartis:
Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture

You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits rewards

Commitment to Diversity and Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

The pay range for this position at commencement of employment is expected to be between $144,000 and $216,000/year; however, while salary ranges are effective from 1/1/24 through 12/31/24, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

Join our Novartis Network:
If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network

East Hanover, NJ
Research & Development
Full Time
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Clinical Document Management Process User Support Team Lead

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